Approval · Notice of Compliance 4819 · 2004
FOSAMAX: Notice of Compliance 4819
Issued July 29, 2004
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 4819
- Date
- July 29, 2004
- Company
- Merck Frosst Canada & Cie, Merck Frosst Canada & Co.Kirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: 70mg once weekly dosing regimen for the treatment of osteoporosis in men
- Therapeutic class
- Bone metabolism regulator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FOSAMAX | Not yet assigned | — |
Medicinal ingredients
- ALENDRONATE SODIUM 70 MG per TAB
- ALENDRONATE SODIUM TRIHYDRATE 70 MG per 75ML